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NCT01199588 · ClinicalTrials.gov registry record · Phase 2
A Study to Investigate the Efficacy, Safety and Tolerability of Nexagon® as a Topical Treatment for Subjects With Venous Leg Ulcers
A Phase 2 study of Venous Leg Ulcers, sponsored by OcuNexus Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 300
- Enrollment target
- 20
- Study locations
NCT01199588: Completed Phase 2 study of Venous Leg Ulcers, sponsored by OcuNexus Therapeutics.
NCT01199588 is a Phase 2 study of Venous Leg Ulcers that has completed, run by OcuNexus Therapeutics. The registered enrollment target is 300 participants, above the 95-participant average among 4 other Venous Leg Ulcers trials with a reported enrollment target (216% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01199588, a Phase 2 study of Venous Leg Ulcers, has completed, sponsored by OcuNexus Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 300 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is for subjects with a venous leg ulcer. The study is being done to determine if NEXAGON plus compression bandaging is more effective that placebo plus compression bandaging.
Conditions Studied
Interventions
- DRUG Nexagon® Low Dose
- DRUG Nexagon® High Dose
- DRUG Nexagon® Vehicle
Study Locations (20)
Arizona
- Associated Foot and Ankle Specialists, LLC - Phoenix
- Aung Foot Health Clinics - Tucson
- Southern Arizona Limb Salvage Alliance - Tucson
California
- Bay Area Foot Care - Castro Valley
- Diabetic Foot & Wound Treatment Center - El Centro
- Advanced Foot Care and Clinical Research Center - Fresno
Pennsylvania
- Penn North Center For Advanced Wound Care - Erie
- Penn North Center For Advanced Wound Care - Kittaning
- Center For Advanced Wound Care - Wyomissing
Florida
- Doctor's Research Network - South Miami
- South Florida Wound Care Group - Tamarac
Illinois
- Northwestern University Feinberg School of Medicine - Chicago
- Passavant Area Hospital - Jacksonville
New York
- St Luke's - Roosevelt Hospital Center Department of Surgery - New York
- Stonybrook Univeristy Medical Center - New York
Texas
- UT Southwestern Medical Center - Dallas
- Saint Paul's Women's Center - Dallas
Nevada
- Advanced Foot & Ankle Center - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2011-05 |
| Est. Completion | 2013-03 |
| Phase | Phase 2 |
What the finished NCT01199588 record still lists
NCT01199588 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 95-participant average among 4 other Venous Leg Ulcers trials with a reported enrollment target (216% higher).
The record links to 1 condition, with Venous Leg Ulcers appearing as the primary indexed condition, and to 3 interventions - of which Nexagon® Low Dose is the first listed.
NCT01199588 names 20 study sites across 10 states, led by Arizona, California, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01199588 about?
NCT01199588 is a clinical study titled "A Study to Investigate the Efficacy, Safety and Tolerability of Nexagon® as a Topical Treatment for Subjects With Venous Leg Ulcers". This study is for subjects with a venous leg ulcer. The study is being done to determine if NEXAGON plus compression bandaging is more effective that placebo plus compression bandaging.
What is the current status of trial NCT01199588?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 300 participants. The study started on 2011-05. Estimated completion is 2013-03.
What conditions does trial NCT01199588 study?
This clinical trial studies the following conditions: Venous Leg Ulcers.
What interventions are being tested in trial NCT01199588?
The interventions under investigation include: Nexagon® Low Dose (DRUG), Nexagon® High Dose (DRUG), Nexagon® Vehicle (DRUG).
Who is sponsoring clinical trial NCT01199588?
This trial is sponsored by OcuNexus Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01199588 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Illinois, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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